Determine Effect of Enzalutamide (MDV3100) on the Androgen Signaling Pathway in Correlation With the Anti-tumor Effects of Enzalutamide

Phase 2

Completed

• Conditions: Metastatic Progressive Castration-resistant Prostate Cancer
• Interventions: Drug: Enzalutamide

• Registration Number: NCT01091103
• Lead Sponsor: Pfizer

Brief Summary

This study is being conducted to determine the effect of enzalutamide on the androgen signaling pathway in correlation with the anti-tumor effects of enzalutamide to identify potential predictors of response or resistance to therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-18
• Study First Submitted: 2010-03-19
• Study First Submitted QC: 2010-03-22
• Study First Posted: 2010-03-23
• Primary Completion: 2012-02-29
• Study Completion: 2013-08-31
• Results First Submitted: 2014-11-10
• Results First Submitted QC: 2014-11-10
• Results First Posted: 2014-11-17
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-19
• Last Update Posted: 2018-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• Confirmed prostate cancer
• Presence of metastatic disease to the bone
• Ongoing androgen deprivation therapy

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Exclusion Criteria

• Severe concurrent disease
• Metastases in the brain

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enzalutamide	Enzalutamide	Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth. Study drug treatment continued until disease progression, unacceptable toxicity, or withdrawal.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Bone Marrow Testosterone	Baseline, Week 9	Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit.; Assessment of intratumoral testosterone was assessed by liquid chromatography mass spectrometry.
Change From Baseline in Bone Marrow Dihydrotestosterone	Baseline, Week 9	Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit.; Assessment of intratumoral dihydrotestosterone was assessed by liquid chromatography mass spectrometry.
Change From Baseline in Bone Marrow Testosterone at Week 9 by Prostate-Specific Antigen (PSA) Response Status	Baseline, Week 9	Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit. Assessment of intratumoral testosterone was assessed by liquid chromatography mass spectrometry.; Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit.; The change from baseline in bone marrow testosterone levels at Week 9 was correlated with PSA response status at Week 9.
Change From Baseline in Bone Marrow Dihydrotestosterone at Week 9 by Prostate-Specific Antigen (PSA) Response Status	Baseline, Week 9	Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit. Assessment of intratumoral dihydrotestosterone was assessed by liquid chromatography mass spectrometry.; Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit.; The change from baseline in bone marrow dihydrotestosterone levels at Week 9 was correlated with PSA response status at Week 9.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants at Week 9 With a Response in Prostate-Specific Antigen (PSA)	Baseline, Week 9	Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit.
Median Time to Study Drug Discontinuation	Duration of study treatment through the data cutoff, up to 3 years.	Exposure to study drug through the data cutoff of 26AUG2011 only. Fifteen participants (25.0%) were still on study drug as of the data cut-off date and were censored at this date.
Change From Baseline in Urinary N-Telopeptide	Baseline, Week 65	Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 65.

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States